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Always Slow, in this Case FDA Moves at Lightning Speed


[Analysis by Jim Dickinson] “FDA is a slow-moving target that bleeds profusely when hit.” (Conventional wisdom from former FDA associate commissioner John Jennings, 1964-88.) FDA has never had a reputation for swift action. Even in the face of nine deaths and 714 sickenings, it took FDA a week in January, 2009 to begin to investigate Peanut Corporation of America’s nationwide salmonella outbreak in peanut butter. It took much longer in 2012 to crack down on New England Compounding Center that ultimately killed 94 people and sickened uncountable others with tainted steroids.

So how to explain New York District’s ability to inject a trade complaint into a routine ongoing medical device facility inspection within hours of its arrival in CDRH’s Silver Spring, MD Office of Compliance? Instead of a crescendo of innocents’ deaths and injuries, the issue for the district on 6/16/2015 was influential Minneapolis attorney Mark DuVal’s complaint for an unnamed client that RMS Medical Products in Chester, NY was marketing adulterated and misbranded infusion devices (see previous story). DuVal’s client was later revealed to be EMED Technologies Corp., an RMS competitor.

What was so electrifying about this complaint that it provoked such an unprecedentedly fast reaction at FDA? The mystery deepens when considered in the light of court-ordered disclosure of emails between DuVal and FDA officials. His 6/16/2015 trade complaint was delivered to CDRH while its addressee, compliance acting director Jan Welch, was out on leave. She didn’t review it until three days later, when, still absent, she forwarded it electronically to her Allegations of Regulatory Misconduct Branch “to be assigned to the correct branch” within her office, according to an email she sent that day to DuVal associate Mark Gardner.

But by then a copy of the DuVal’s complaint was already in the hands of the New York district investigator conducting the RMS inspection, Jacqueline Warner, who received it within hours of its 6/16 arrival at CDRH in Silver Spring. Who did this, and why so fast, before the complaint had even been officially logged in? Was it the same person(s) DuVal had in mind four days earlier when on 6/12 he alerted as a “courtesy” three New York District Office officials that the trade complaint would be coming to Welch, adding: “According to our sources an FDA inspection of the firm is currently underway”?

Even more mysterious, despite all this speed and focusing by DuVal and someone in FDA, when Warner wrote up her FDA-483 list of inspectional observations and issued it to RMS, she omitted all mention of the complaint. Instead, Warner’s 16 observations dealt with four unfiled MDRs, four device design issues, and various relatively minor GMP issues.

Sometime during the FDA-483’s eight-month bureaucratic deliberation that glaring omission was rectified. When Warner’s boss, NY District director Ronald M. Pace (one of the three District officials alerted in DuVal’s 6/12 “courtesy” email), issued RMS a Warning letter 2/26/2016, it focused first on the DuVal trade complaint issues before moving on to Warner’s FDA-483 issues, asserting that the company’s Freedom60 Syringe and Freedom Edge Pump were both adulterated and misbranded for the reasons DuVal had alleged in his complaint.

Who reinserted the trade complaint into the district’s lengthy internal review of the inspection? For that matter, who told DuVal about the ongoing inspection at RMS more than 11 days before it ended? The same person or persons who rushed his trade complaint to investigator Warner? And why didn’t she include its issues in her FDA-483?

One of the other two New York FDAers DuVal tipped off about his impending trade complaint was northeast regional director Charles Becoat, now no longer with FDA, who previously worked in DuVal’s home town as FDA Minneapolis District director. Was that co-location mere happenstance?

On 3/31 this year, RMS CEO and chairman Andy Sealfon repeated a request he first made 11/1/2016 to CDRH seeking an explanation for employees’ actions against his company, writing that “personnel in your office displayed unusual favoritism toward attorney DuVal and his firm to our great disadvantage.” Neither this nor the first letter produced any response from CDRH leadership, Sealfon told us this week.

Meanwhile, Sealfon has sent us this comment on our previous article about this matter, and especially the solicited comments appended to it from EMED Technologies president Paul Lambert and by DuVal:

“I regret the irrelevant remarks expressed by Mr. Lambert in reply to your ‘letter’, but his final statements are misleading and not factual. While the Patent dispute process is continuing, the two EMED patents to which he refers have so far been determined invalid by the USPTO. While these matters have not been settled, we are confident that RMS will prevail. I remind your readers that there have been no supportable ‘findings’ of violations by the FDA, and no injuries to patients during more than 20 years of manufacture and millions of satisfied patient infusions which continue without interruption.

“I am disappointed by comments made by Mr. DuVal, on and off the record, about the accuracy of the trade complaint. It was and remains his responsibility to verify the content of his firm’s “anonymous’ complaint, not the FDA. However, we are certain that the CDRH Office of Compliance did not verify the devastating June 16, 2015 DuVal trade complaint, because it was in the possession of the New York District Office that day and used by the inspector to significantly extend an otherwise routine inspection.

“DuVal’s comments provide no insight as to where the trade complaint originated from, how his firm verified its accuracy before filing with FDA and how FDA vetted the complaint, nor how it managed to get into the investigator’s hands hours before the email containing the complaint was actually received by the FDA Office of Compliance (who didn’t respond to it for another three days).”

Sent a draft of this article, Mark DuVal commented:

“In part, the story is flattering because so much clout is attributed to our firm. In part, it ascribes more clout than we have. Two points: first, we are respected by FDA and, we greatly respect them. Second, if that helps our clients get their side of the story and the truth told then we’ve done our job. Our job is to take the facts and the law and regulations and persuasively present them to the FDA. We do great work and we are proud of it. Again, the results speak for themselves because FDA agreed with our position.”